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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM; STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
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BOSTON SCIENTIFIC CORPORATION ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM; STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING Back to Search Results
Model Number 24653
Device Problems Activation Failure (3270); Poor Visibility (4072)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/04/2023
Event Type  Injury  
Event Description
It was reported that the stent failed to fully expand, and the stent was difficult to see under fluoroscopy.A 6x100, 130 cm eluvia drug-eluting vascular stent system was selected for use in a percutaneous transluminal angioplasty and stenting procedure in the superficial femoral artery (sfa).During the procedure, the stent did not deploy well because the stent strut was hard to see under fluoroscopy.The procedure was completed with a different device.No patient complications were reported.
 
Manufacturer Narrative
B5 describe event or problem: updated.E1 initial reporter first name & initial reporter last name: updated.
 
Event Description
It was reported that the stent failed to fully expand, and the stent was difficult to see under fluoroscopy.A 6x100, 130 cm eluvia drug-eluting vascular stent system was selected for use in a percutaneous transluminal angioplasty and stenting procedure in the superficial femoral artery (sfa).During the procedure, the stent did not deploy well because the stent strut was hard to see under fluoroscopy.The procedure was completed with a different device.No patient complications were reported.It was further reported that a contralateral approach was used to access the lesion, which was pre and post dilated.The stent was not fully expanding during implant, so an additional stent was necessary to treat the lesion.
 
Manufacturer Narrative
Device eval by manufacturer: returned product consisted of an eluvia self-expanding stent system.The outer sheath, tip, inner sheath, and the remainder of the device were checked for damage.Visual examination revealed multiple kinks along the sheath.Microscopic examination revealed no additional damages.The thumbwheel lock and pull rack was still in the manufactured position.The stent was still inside the sheath.The device was x-rayed, and the stent could be seen.
 
Event Description
It was reported that the stent failed to fully expand, and the stent was difficult to see under fluoroscopy.A 6x100, 130 cm eluvia drug-eluting vascular stent system was selected for use in a percutaneous transluminal angioplasty and stenting procedure in the superficial femoral artery (sfa).During the procedure, the stent did not deploy well because the stent strut was hard to see under fluoroscopy.The procedure was completed with a different device.No patient complications were reported.It was further reported that a contralateral approach was used to access the lesion, which was pre and post dilated.The stent was not fully expanding during implant, so an additional stent was necessary to treat the lesion.
 
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Brand Name
ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM
Type of Device
STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
ballybrit business park
galway
EI  
Manufacturer Contact
jeff wallner
4100 hamline ave n
arden hills, MN 55112
6515811560
MDR Report Key16259581
MDR Text Key308343446
Report Number2124215-2023-03284
Device Sequence Number1
Product Code NIU
Combination Product (y/n)Y
Reporter Country CodeKS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 05/10/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/27/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/28/2023
Device Model Number24653
Device Catalogue Number24653
Device Lot Number0026749539
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/13/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/28/2021
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age65 YR
Patient SexMale
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